NCT05839353

Brief Summary

Dyspnea is defined as a subjective feeling of discomfort in breathing. In respiratory pathologies, dyspnea can be indicative of lung cancer or its aggravation, or even be the most important symptom of the end of life. The prevalence of dyspnea is high in patients with lung cancer, ranging from 50 to 87%. Dyspnea can exacerbate at any time in the course of care for the patient with lung cancer, causing respiratory distress or Acute Respiratory Failure (ARF) and putting the prognosis at stake. ARF justifies urgent and effective care, and in pre-hospital, it is based on the call to the Emergency Medical Aid Service (SAMU). The communication of information on the patient's condition in ARF to the SAMU must be as clear and precise as possible in order to avoid medical errors, inappropriate decisions and therefore a loss of opportunity for the patient. In Oncology, caregivers often assume the role of "decision maker" and provide monitoring and assessment of symptoms, including dyspnea. A qualitative study on the experience of caregivers during dyspnea occurring in patients with lung cancer or obstructive bronchopneumopathy revealed an altered emotional state of caregivers, such as anxiety, stress and feeling of helplessness, especially when respiratory deterioration occurs suddenly at night. The unmet need for information could compromise the sense of self-efficacy among caregivers. In this context of monitoring symptoms in lung cancer at home, caregivers are the first witnesses of respiratory distress in their loved ones. However, faced with the sudden deterioration of breathing, they risk forgetting to communicate essential information when calling the SAMU. Since 2014, the High Authority for Health (HAS) has been recommending the use of the SBAR tool (Situation, Background, Assessment Recommendation) to facilitate communication between professionals. Its effectiveness has been proven both in improving knowledge and in the quality of communication. This is why training in the use of the SBAR (Situation, Background, Assessment Recommendation) tool could be extrapolated to caregivers with regard to the responsibilities they must assume in the management of home care, including lung cancer to deal with respiratory distress.The Serious Game (SG) is an innovative educational tool adapted to training in the field of health.It is an interactive web-based software allowing the repetitive training of medical procedures in a virtual environment, in the form of video games for active, experiential and problem-based learning, without the need to involve patients and therefore without risk.The aim of the research is to provide training in the SBAR (Situation, Background, Assessment Recommendation) tool in the form of a Serious Game for carers of patients with lung cancer in order to improve the feeling of self-efficacy in the management of respiratory distress at home.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

1.8 years

First QC Date

April 20, 2023

Last Update Submit

June 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Effect of training in the SBAR tool by serious game on the feeling of self-efficacy of carers of patients with lung cancer in the face of a situation of simulated respiratory distress.

    Generalized Self-Efficacy (GSE) scale \_ 10 question / minimum value = 10 ; maximum value = 40 / Higher scores mean a better outcome (high sense of self-efficacy)

    28 days

Secondary Outcomes (2)

  • Effect of training in the SBAR tool by serious game on anxiety

    28 and 90 days

  • Effect of training in the SBAR tool by serious game on stress

    28 and 90 days

Study Arms (2)

simulated training by Serious Game (SG)

Simulated training (by SG) for the use of the SBAR tool associated with the usual instructions issued in routine care, on the management of dyspnea

Other: SBAR training by serious game

usual instructions issued in routine care

Usual instructions issued in routine care, on the management of dyspnea

Interventions

SBAR training by serious game

simulated training by Serious Game (SG)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Designated as a resource person by a patient newly diagnosed with lung cancer

You may qualify if:

  • Over 18 years old
  • Designated as a resource person by a patient newly diagnosed with lung cancer and receiving their first course of anti-cancer treatment (chemotherapy, hormone therapy or targeted therapy)
  • Providing daily unpaid technical, psychological and social assistance
  • Having given free, informed, express oral consent

You may not qualify if:

  • Person deprived of liberty by judicial or administrative decision, and person subject to legal protection (guardianship or curators)
  • Having a cancerous pathology
  • Illiterate
  • Do not have access to computer equipment (computer, tablet or smart phone)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reunion Island University Hospital

Saint-Pierre, 97448, France

Location

Study Officials

  • Danielle REYNAUD

    CHU Reunion Island

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2023

First Posted

May 3, 2023

Study Start

July 1, 2023

Primary Completion

April 1, 2025

Study Completion

August 1, 2025

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations